Strengthened position following intellectual property and regulatory approvals
(Thomson Reuters ONE) -
7 May 2010, Lysaker, Norway: Pronova BioPharma ASA (OSE: PRON.OL) reports
further solid progress in the first quarter of 2010, with total revenues of NOK
455.4 million and EBITDA of NOK 185.2 million. Total shipments in the quarter
reached 468 tonnes. The group's position has been further strengthened, as
patents have been granted in Europe for the group's proprietary stripping
technology for the removal of environmental pollutants and cholesterol, and an
intention to grant patent has been achieved in the USA. Following the increasing
regulatory and public focus on the potential harmful effects of environmental
pollutants in omega-3 fish-oils, these patents constitute important intellectual
property assets for Pronova BioPharma.
Underlying end-user sales continued to grow in the first quarter of 2010, with
total end-user sales amounting to 303 million, up 31 per cent compared to the
same quarter last year (source: IMS). In the USA , Pronova BioPharma's partner
GlaxoSmithKline (GSK) initiated a direct- to-consumer advertising campaign for
Omacor(®)/Lovaza(TM) in the quarter, including TV advertising launched end of
March. The campaign, which is expected to last for approximately 12 months, is
significantly increasing the promotional investment in the product.
The Kalundborg manufacturing facility was approved by the US Food and Drug
Administration in April 2010, earlier than expected.
Overall, total group revenues grew by 27 per cent, to NOK 455.4 million (NOK
358.6 million), as a result of continued growth in demand and the group's
operational flexibility.
Gross margin was 76.9 per cent (74.4 per cent) in the quarter, positively
impacted by the inventory stocking of finished goods and negatively impacted by
the lower price per tonne shipped.
EBITDA was NOK 185.2 million (NOK 164.1 million), an increase of 12.9 per cent
compared to the same period last year. The EBITDA margin was 40.7 per cent (45.7
per cent).
The group's operating profit decreased in comparison with the same period in
2009, to NOK 99.3 million (NOK 120.8 million). The growth in gross profit is
offset by increased operating expenses as a result of full operation in Denmark
and increased legal costs.
Net financial items were negative at NOK 46.2 million (negative NOK 111.6
million), with net interest expenses of NOK 27.5 million. The Norwegian krone
(NOK) was strengthened in the quarter, which resulted in currency effects from
inter-company borrowings between Pronova BioPharma Norge AS and Pronova
BioPharma Danmark A/S. Currency effects of inter-company borrowings adversely
impacted the financial items by NOK 47.4 million (NOK 101.9 million). Net profit
for the quarter was NOK 32.7 million (NOK 3.3 million).
EU patents have been granted for the group's proprietary stripping technology
for the removal of environmental pollutants and cholesterol, and an intention to
grant patent has been achieved in the USA. Following the increasing regulatory
and public focus on the potential harmful effects of environmental pollutants in
omega-3 fish-oils, these patents constitute important intellectual property
assets for Pronova BioPharma.
The ongoing litigation process against Teva Pharmaceuticals USA, Inc., Apotex
Inc. and Par Pharmaceutical Inc. in the United States District Court for the
District of Delaware progressed according to agreed schedule. The case is
currently in the discovery phase, and documents have been exchanged. Pronova
BioPharma will vigorously defend and enforce its patents.
The preliminary clinical trial on alginate capsules to study the alginate
characteristics in humans identified that further optimisation of the product is
required. Optimisation of the capsule technology is expected to be finalised by
year end, delaying the project by approximately nine months.
Pronova BioPharma has initiated evaluation of the results from the GISSI -HF
study, and expects to file for a label extension or for a new indication based
on the data from the study in the third quarter of 2010. The R&D initiatives on
several PRB candidates (next generation omega-3 derived pharmaceuticals) are
advancing according to plan. Pending final pre-clinical documentation on the
products, the group expects to advance into Phase I clinical trials late in
2010.
Two lawsuits were concluded in April. The German Federal High Court of Justice
dismissed Pronova BioPharma's appeal as a result of an appeal against the
Federal Patent Court's ruling from November 2007, which declared the Omacor(®)
patent in Germany invalid. In Italy, the District Court of Milan decided to
cease the nullity action against Pronova BioPharma's patent.
Mr. Hamed Brodersen has been appointed VP Investor Relations and Communications
and will take up his position on 1 June 2010. Mr Brodersen has extensive
investor relations and communication experience from various companies in the
process industry, and was most recently VP Communications at NorSun AS.
The R&D programmes are continuing to mature, with a second new chemical entity
expected to enter clinical phase 1 in late 2010, implying that R&D costs will
increase later this year. As previously communicated, legal costs are also
expected to be higher in 2010. Expected partner demand in 2010 remains unchanged
around 1 800 to 2 000 tonnes. Contractual price adjustments related to crude
fish-oil are expected to have a negative impact on 2010 sales prices. However,
if the crude fish-oil price stays at current level, the group anticipates API
price levels to return to previous levels in 2011.
The US Food and Drug Administration (FDA) approved the Kalundborg plant in April
2010, ahead of expected schedule, securing the operational flexibility to supply
increased volumes to the market. A re-focused growth strategy has therefore been
initiated with increased focus on driving the market potential in existing
markets and launches of Omacor(®)/Lovaza(TM) in new territories. Life-cycle
initiatives are intensified, and there is continued focus on the development of
new products in order to secure future profitable growth.
Pronova BioPharma's major investment programme related to capacity increases was
completed in 2009 and a continued strong cash flow from operations is expected
in the foreseeable future. This enables the company to change its long-term
dividend policy to distribute 25 to 75 per cent of the company's annual net
profit as dividend. The board expects that dividend will be paid for the first
time in 2011, based on net profit achieved in 2010. Dividend payments will be
dependent on future production capacity requirements, new opportunities and the
general financial position.
The complete first quarter report is available at www.newsweb.no
The company will present the results today at 08:30AM CET/07:30 GMT. The
presentation, will be webcasted live and can be accessed at www.pronova.com.
(Internet explorer web browser needed). Web cast attendants may send questions
electronically during the session.
For further information, please contact:
Hilde H Steineger, Vice president IR: +47 48 00 42 40
Synne Røine, CFO: +47 22 53 49 10
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)
[HUG#1412918]
Q1 2010 report: http://hugin.info/137506/R/1412918/365062.pdf
Q1 2010 presentation: http://hugin.info/137506/R/1412918/365074.pdf
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Datum: 07.05.2010 - 01:01 Uhr
Sprache: Deutsch
News-ID 1014260
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